Category: Audit
By The Pro QC Quality Assurance Team
Pro QC International partners with clients with ease and shares in their success. The medical device industry must produce safe and effective products to diagnose and treat disease. Each year, industry requirements become more stringent as regulatory bodies, standards organizations, and patients expect more in safety and effectiveness. To help …
By The Pro QC Quality Assurance Team
Social compliance issues have been a growing concern for several years now and only continue to rise as working conditions have taken a backseat during the Covid-19 pandemic. The Rana Plaza disaster killed over a thousand people and maimed over two thousand more when the eight-story commercial building, housing garment …
Check out our latest video and let us know what you think!
We’ve used 5W2H to discuss Product Quality Control before, and now we’re using this popular tool to provide insight regarding process audits. Who? Quality auditors are often certified and/or have other applicable training specific to the types of audits they perform. Quality auditors must be professional, ethical and objective. They …
I’ve recently returned from a visit to our offices in China where I was able to attend a C-TPAT audit with our Supplier Development Manager, Jean Champlain. A C-TPAT audit isn’t quite as common as a general QMS or ISO 9001 evaluation, but the information generated has significant value when …
Our recent newsletter Feature Article highlighted ISO 13485 audits applicable to the medical device industry. A common question we receive in relation to regulatory requirements in the U.S. is the relationship to FDA 21 CFR Part 820. To ensure medical devices are safe and effective, the U.S. Food and Drug …
ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, …
